Medical tubes for selective mechanical ventilation of the lungs

ABSTRACT

A single lumen endobronchial tube for selective mechanical ventilation of the lungs can include a medical tube having a single lumen with an opening at the proximal end of the tube being adapted for connection to an external mechanical ventilation device, and an opening at the distal end being adapted for delivery of a medical gas; a wall extending throughout the tube&#39;s entire length having an internal wall surface, an external wall surface and a thickness therebetween, a portion of the wall having an aperture and a shaft adapted to house a mechanism for sealing the aperture; a distal bronchial cuff and at least a first proximal tracheal cuff positioned along the external wall surface and adapted to expand radially outward.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/082,664, filed Nov. 18, 2013, now U.S. Pat. No. 9,789,271, which is acontinuation of U.S. application Ser. No. 13/021,040, filed on Feb. 4,2011, now U.S. Pat. No. 8,584,678, and claims the benefit of andpriority to U.S. Provisional Application Ser. No. 61/301,435, filed Feb.4, 2010. These applications are hereby incorporated herein by referencein their entireties for the teachings therein.

FIELD

The embodiments disclosed herein relate to medical tubes for selectivemechanical ventilation of the lungs, and more particularly to singlelumen endobronchial tubes for selective mechanical ventilation of theleft lung or the right lung.

BACKGROUND

The body requires a certain volume of air to be inhaled and exhaled tomaintain the correct levels of oxygen and carbon dioxide within thetissues. Tissue damage, which leads eventually to death, occurs if thelevel of oxygen becomes too low or the amount of carbon dioxide becomestoo high. The body is therefore critically dependent on breathing tomaintain life. In medicine, mechanical ventilation is a method tomechanically assist or replace spontaneous breathing. A medicalventilator moves breathable air into and out of the lungs, to providethe mechanism of breathing for a patient who is physically unable tobreathe, or breathing insufficiently. Ventilators are chiefly used inintensive care medicine and emergency medicine (as standalone units) andin anesthesia (as a component of an anesthesia machine).

SUMMARY

Single lumen endobronchial tubes for selective mechanical ventilation ofthe left lung or the right lung are disclosed herein.

According to aspects illustrated herein, there is provided a singlelumen endobronchial tube adapted for isolating a first lung of a patientand ventilating a second lung of the patient that includes a medicaltube comprising a tracheal portion and a bronchial portion having acommon single lumen and a common tube wall thickness, wherein a proximalend of the tracheal portion includes an opening adapted for connectionto an external mechanical ventilation device, and wherein a distal endof the bronchial portion includes an opening adapted for delivery of amedical gas; at least a first tracheal inflatable cuff positioned aroundan external surface of the tracheal portion and adapted to expandradially outward sealing against the trachea of the patient; a bronchialinflatable cuff positioned around an external surface of the bronchialportion and adapted to expand radially outward against the left mainstem bronchi of the patient; an aperture positioned between the trachealportion and the bronchial portion and adapted to deliver an amount ofmedical gas to the second lung of the patient; and a mechanismpositioned within the wall of the tube, the mechanism adapted to controlthe amount of medical gas passing through the aperture.

According to aspects illustrated herein, there is provided a singlelumen endobronchial tube adapted for isolating a first lung of a patientand ventilating a second lung of the patient that includes a medicaltube comprising tracheal portion and a bronchial portion having a commonsingle lumen and a common tube wall thickness, wherein a proximal end ofthe tracheal portion includes an opening adapted for connection to anexternal mechanical ventilation device, and wherein a distal end of thebronchial portion includes an opening adapted for delivery of a medicalgas; a first tracheal inflatable cuff positioned around an externalsurface of the tracheal portion and adapted to expand radially outwardsealing against the trachea of the patient; a bronchial inflatable cuffpositioned around an external surface of the bronchial portion andadapted to expand radially outward against the left main stem bronchi ofthe patient; a bronchial balloon blocker positioned in the common singlelumen of the bronchial portion adapted to expand radially outwardsealing the common single lumen; a second tracheal inflatable cuffpositioned around an external surface of the tracheal portion andadapted to expand radially outward at a respective distal locationrelative to the first tracheal inflatable cuff sealing against thetrachea of the patient; and an aperture positioned between the firsttracheal inflatable cuff and the second inflatable cuff and adapted todeliver an amount of medical gas to the second lung of the patient,wherein the second tracheal cuff is adapted to control the amount ofmedical gas passing through the aperture.

According to aspects illustrated herein, there is provided a singlelumen endobronchial tube adapted for isolating a first lung of a patientand ventilating a second lung of the patient that includes a medicaltube comprising a tracheal portion and a bronchial portion having acommon single lumen and a common tube wall thickness, wherein a proximalend of the tracheal portion includes an opening adapted for connectionto an external mechanical ventilation device, and wherein a distal endof the bronchial portion includes an opening adapted for delivery of amedical gas; at least a first tracheal inflatable cuff positioned aroundan external surface of the tracheal portion and adapted to expandradially outward sealing against the trachea of the patient; a bronchialinflatable cuff positioned around an external surface of the bronchialportion and adapted to expand radially outward against the left mainstem bronchi of the patient; a bronchial balloon blocker positioned inthe common single lumen of the bronchial portion adapted to expandradially outward sealing the common single lumen; an aperture positionedbetween the tracheal portion and the bronchial portion and adapted todeliver an amount of medical gas to the second lung of the patient; andan expandable balloon adapted to control the amount of medical gaspassing through the aperture.

According to aspects illustrated herein, there is provided a singlelumen endobronchial tube that includes a medical tube comprising asingle lumen with an opening at each of opposed distal and proximal endsof the tube, the opening at the proximal end of the tube being adaptedfor connection to an external mechanical ventilation device, and theopening at the distal end of the tube being adapted for delivery of amedical gas; a wall extending throughout the tube's entire length havingan internal wall surface, an external wall surface and a thicknesstherebetween, a portion of the wall having an aperture and a shaftadapted to house a mechanism for sealing the aperture; a distalbronchial cuff positioned along the external wall surface and adapted toexpand radially outward; and at least a first proximal tracheal cuffpositioned along the external wall surface and adapted to expandradially outward.

According to aspects illustrated herein, there is provided a singlelumen endobronchial tube of the present disclosure that includes amedical tube comprising a single lumen with an opening at each ofopposed distal and proximal ends of the tube, the opening at theproximal end of the tube being adapted for connection to an externalmechanical ventilation device, and the opening at the distal end of thetube being adapted for delivery of a medical gas; a wall extendingthroughout the tube's entire length having an internal wall surface, anexternal wall surface and a thickness therebetween, a portion of thewall having an aperture; a distal bronchial cuff positioned along theexternal wall surface and adapted to expand radially outward; a firstproximal tracheal cuff positioned along the external wall surface andadapted to expand radially outward; and a second proximal tracheal cuffpositioned along the external wall surface and adapted to expandradially outward at a respective distal location relative to theaperture.

According to aspects illustrated herein, there is provided a singlelumen endobronchial tube of the present disclosure that includes amedical tube comprising a single lumen with an opening at each ofopposed distal and proximal ends of the tube, the opening at theproximal end of the tube being adapted for connection to an externalmechanical ventilation device, and the opening at the distal end of thetube being adapted for delivery of a medical gas; a wall extendingthroughout the tube's entire length having an internal wall surface, anexternal wall surface and a thickness therebetween, a portion of thewall having an aperture; an expandable balloon adapted to control theamount of medical gas passing through the aperture; a distal bronchialcuff positioned along the external wall surface and adapted to expandradially outward; and at least a first proximal tracheal cuff positionedalong the external wall surface and adapted to expand radially outward.

According to aspects illustrated herein, there is provided a method forone-lung ventilation of a lung of an air-breathing animal that includesproviding a single lumen endobronchial tube, the single lumenendobronchial tube comprising a medical tube having a single lumen withan opening at each of opposed distal and proximal ends of the tube, theopening at the proximal end of the tube being adapted for connection toan external mechanical ventilation device, and the opening at the distalend of the tube being adapted for delivery of a medical gas; a wallextending throughout the tube's entire length having an internal wallsurface, an external wall surface and a thickness therebetween, aportion of the wall having an aperture and a shaft adapted to house amechanism for sealing the aperture; a distal bronchial cuff positionedalong the external wall surface and adapted to expand radially outward;at least a first proximal tracheal cuff positioned along the externalwall surface and adapted to expand radially outward; and a distalintraluminal balloon blocker at a respective distal location relative tothe aperture; positioning the single lumen endobronchial tube in thepulmonary airway of the animal such that the distal bronchial cuff is inthe left main stem bronchus, and the first proximal tracheal cuff is inthe trachea, wherein a distal end of the medical tube is positionedbeyond the carina of the animal; connecting the proximal end of themedical tube to the external mechanical ventilation device; inflatingthe distal bronchial cuff radially outwardly to seal against thesurrounding bronchus of the left lung; inflating the proximal trachealcuff radially outwardly to seal against the surrounding trachea of theanimal; and performing a step selected from one of inflating the distalintraluminal balloon blocker radially outwardly to occlude the lumen ofthe tube and thereby effectively occlude the left lung, whereby anairway from the ventilation device to the animal's right lung ismaintained via the aperture or sealing the aperture by activating themechanism housed in the shaft of the wall of the tube to block theaperture and thereby effectively occlude the right lung, whereby anairway from the ventilation device to the anima's left lung ismaintained via the opening at the distal end of the tube.

BRIEF DESCRIPTION OF THE DRAWINGS

The presently disclosed embodiments will be further explained withreference to the attached drawings, wherein like structures are referredto by like numerals throughout the several views. The drawings shown arenot necessarily to scale, with emphasis instead generally being placedupon illustrating the principles of the presently disclosed embodiments.

FIG. 1 is a side view of an embodiment of a single lumen endobronchialtube of the present disclosure.

FIG. 2A and FIG. 2B are cross-sectional plan views taken along line 2-2of FIG. 1.

FIG. 2A shows a distal intraluminal balloon of the single lumenendobronchial tube in an inflated state. FIG. 2B shows a distalintraluminal balloon of the single lumen endobronchial tube in adeflated state.

FIG. 3 shows a cross-sectional plan view taken along line 3-3 of FIG. 1.

FIG. 4 shows a partial perspective view of the single lumenendobronchial tube of FIG. 1 showing an embodiment of a mechanismadapted to control the amount of medical gas passing through an apertureprovided through a wall of the tube.

FIG. 5 shows a component of the mechanism of FIG. 4 adapted to controlthe amount of medical gas passing through the aperture provided throughthe wall of the tube.

FIG. 6 shows a cutaway side view taken along line 6-6 of FIG. 4 when themechanism is adapted to allow the passage of medical gas through theaperture provided through the wall of the tube.

FIG. 7 shows a cutaway side view taken along line 6-6 of FIG. 4 when themechanism is adapted to prevent the passage of medical gas through theaperture provided through the wall of the tube.

FIG. 8 shows a cross-sectional view taken along line 8-8 of FIG. 6.

FIG. 9 shows a cross-sectional view taken along line 9-9 of FIG. 7.

FIG. 10 shows a cross-sectional plan view taken along line 10-10 of FIG.4.

FIG. 11 shows a cutaway side view of the single lumen endobronchial tubeof FIG. 1 showing an embodiment of a mechanism adapted to control theamount of medical gas passing through an aperture provided through awall of the tube.

FIG. 12 shows a cutaway side view of the single lumen endobronchial tubeof FIG. 1 showing an embodiment of a mechanism adapted to control theamount of medical gas passing through an aperture provided through awall of the tube.

FIG. 13 shows a cross-sectional view taken along line 13-13 of FIG. 12.

FIG. 14 and FIG. 15 show cutaway side views of the single lumenendobronchial tube of FIG. 1 showing an embodiment of a mechanismadapted to control the amount of medical gas passing through an apertureprovided through a wall of the tube. As illustrated in FIG. 14, themechanism is adapted to allow the passage of medical gas through theaperture provided through the wall of the tube. As illustrated in FIG.15, the mechanism is adapted to prevent the passage of medical gasthrough the aperture provided through the wall of the tube.

FIG. 16 shows a cutaway side view of the single lumen endobronchial tubeof FIG. 1 showing an embodiment of a mechanism adapted to control theamount of medical gas passing through an aperture provided through awall of the tube. As illustrated in FIG. 16, the mechanism is adapted toallow the passage of medical gas through the aperture provided throughthe wall of the tube.

FIG. 17 and FIG. 18 show cutaway side views of the single lumenendobronchial tube of FIG. 1 showing an embodiment of a mechanismadapted to control the amount of medical gas passing through an apertureprovided through a wall of the tube. As illustrated in FIG. 17, themechanism is adapted to allow the passage of medical gas through theaperture provided through the wall of the tube. As illustrated in FIG.18, the mechanism is adapted to prevent the passage of medical gasthrough the aperture provided through the wall of the tube.

FIG. 19 shows a cutaway side view of the single lumen endobronchial tubeof FIG. 1 showing an embodiment of a mechanism adapted to control theamount of medical gas passing through an aperture provided through awall of the tube.

FIG. 20 shows a cutaway side view of the single lumen endobronchial tubeof FIG. 1 showing an embodiment of a mechanism adapted to control theamount of medical gas passing through an aperture provided through awall of the tube.

FIG. 21 and FIG. 22 show cutaway side views of the single lumenendobronchial tube of FIG. 1 showing an embodiment of a mechanismadapted to control the amount of medical gas passing through an apertureprovided through a wall of the tube. As illustrated in FIG. 21, themechanism is adapted to allow the passage of medical gas through theaperture provided through the wall of the tube. As illustrated in FIG.22, the mechanism is adapted to prevent the passage of medical gasthrough the aperture provided through the wall of the tube.

FIG. 23 and FIG. 24 show cutaway side views of the single lumenendobronchial tube of FIG. 1 showing an embodiment of a mechanismadapted to control the amount of medical gas passing through an apertureprovided through a wall of the tube. As illustrated in FIG. 23, themechanism is adapted to allow the passage of medical gas through theaperture provided through the wall of the tube. As illustrated in FIG.24, the mechanism is adapted to prevent the passage of medical gasthrough the aperture provided through the wall of the tube.

FIG. 25 and FIG. 26 show cutaway side views of the single lumenendobronchial tube of FIG. 1 showing an embodiment of a mechanismadapted to control the amount of medical gas passing through an apertureprovided through a wall of the tube. As illustrated in FIG. 25, themechanism is adapted to allow the passage of medical gas through theaperture provided through the wall of the tube. As illustrated in FIG.26, the mechanism is adapted to prevent the passage of medical gasthrough the aperture provided through the wall of the tube.

FIG. 27 shows a schematic view of the single lumen endobronchial tube ofFIG. 1 positioned in a person for the selective ventilation of the rightlung.

FIG. 28 shows a schematic view of the single lumen endobronchial tube ofFIG. 1 positioned in a person for the selective ventilation of the leftlung.

FIG. 29 is a side view of an embodiment of a single lumen endobronchialtube of the present disclosure.

FIG. 30 shows a schematic view of the single lumen endobronchial tube ofFIG. 29 positioned in a person for the selective ventilation of the leftlung.

FIG. 31 is a side view of an embodiment of a single lumen endobronchialtube of the present disclosure.

FIG. 32 shows a cross-sectional plan view taken along line 32-32 of FIG.31.

FIG. 33 and FIG. 34 show cutaway side views of the single lumenendobronchial tube of FIG. 31 showing an embodiment of a balloon adaptedto control the amount of medical gas passing through an apertureprovided through a wall of the tube. As illustrated in FIG. 33, theballoon is adapted to allow the passage of medical gas through theaperture provided through the wall of the tube. As illustrated in FIG.34, the balloon is adapted to prevent the passage of medical gas throughthe aperture provided through the wall of the tube.

FIG. 35 shows a schematic view of the single lumen endobronchial tube ofFIG. 31 positioned in a person for the selective ventilation of the leftlung.

FIG. 36 is a side view of an embodiment of a single lumen endobronchialtube of the present disclosure.

FIG. 37 shows a cross-sectional plan view taken along line 37-37 of FIG.36.

FIG. 38 shows a schematic view of the single lumen endobronchial tube ofFIG. 36 positioned in a person for the selective ventilation of theright lung.

While the above-identified drawings set forth presently disclosedembodiments, other embodiments are also contemplated, as noted in thediscussion. This disclosure presents illustrative embodiments by way ofrepresentation and not limitation. Numerous other modifications andembodiments can be devised by those skilled in the art which fall withinthe scope and spirit of the principles of the presently disclosedembodiments.

DETAILED DESCRIPTION

Mechanical ventilation has become the most commonly used mode of lifesupport in medicine today. Widely used in management of acutely illsurgical and ICU patients, mechanical ventilation can also be used inthe chronic support of patients with a wide spectrum of chronic diseasesthat can cause respiratory failure.

As used herein, the term “anesthesia machine” refers to a machine usedby an anesthesiologist to support the administration of anesthesia. Themost common type of anesthesia machine, the continuous-flow anesthesiamachine, is designed to provide an accurate and continuous supply ofmedical gases (such as oxygen and nitrous oxide), mixed with an accurateconcentration of anesthetic vapor (such as isoflurane), and deliver thisto the patient at a safe pressure and flow. Modern machines incorporatea medical ventilator, suction unit, and patient-monitoring devices.

As used herein, the term “positive airway pressure” or “PAP” refers to amethod of respiratory ventilation used primarily in the treatment ofsleep apnea. PAP ventilation is also commonly used for critically illpatients in hospital with respiratory failure, and in newborn infants(neonates). “Bi-level Positive Airway Pressure” or “BIPAP” refers to aform of temporary respiratory support for patients that have difficultybreathing. Each time the patient breathes, the BIPAP machine assists thepatient by applying air pressure to the lungs while the patient isbreathing out (exhaling or expiration) in order to hold open the airsacs in the lungs. “Continuous Positive Airway Pressure” or “CPAP”refers to the application of positive pressure to the airways of thespontaneously or mechanically breathing patient throughout therespiratory cycle. A CPAP machine uses continuous air pressure toproduce added oxygen or simply to help keep the airways in the lungsopen. The air pressure keeps the airways functioning properly and helpsthe individual breathe additional oxygen more easily. CPAP machines wereinitially used mainly by patients for the treatment of sleep apnea athome, but now are in widespread use across intensive care units as aform of ventilation.

As used herein, the term “mechanical ventilation” refers to a method tomechanically assist or replace spontaneous breathing.

As used herein, the term “external mechanical ventilation device” refersto a machine to mechanically assist or replace spontaneous breathing.Examples of external mechanical ventilation devices include, but are notlimited to, hand-controlled ventilators and mechanical ventilators suchas transport ventilators, ICU ventilators, and PAP ventilators (BiPAPmachine, CPAP machine).

As used herein, the term “medical gas” includes gases such as compressedair, oxygen, carbon dioxide, helium, nitrogen and nitrous oxide.

As used herein, the term “one-lung ventilation”, “OLV”, “independentlung ventilation” or “ILV” consists of mechanical ventilation of aselected lung and exposure or intentional airway blocking to the other.OLV is required for a number of thoracic procedures, including, but notlimited to, lung surgery, esophageal surgery, aortic surgery,mediastinal surgery, minimally invasive lung surgery, minimally invasiveheart surgery, robotic heart surgery and robotic lung surgery. In aconventional OLV procedure, a double-lumen endotracheal tube, anendobronchial blocker, or a single lumen tube may be used. Double-lumenendotracheal tubes and endobronchial blockers function differently.Double-lumen endotracheal tubes isolate ventilation, separating theright and left pulmonary units using two separate endotracheal tubes. Anendobronchial blocker blocks ventilation to a pulmonary segment.Endobronchial blockers are typically balloon tipped catheters that areplaced in the portion of the pulmonary tree that is to be blocked(usually the right or left main stem bronchus). Ventilation to thepulmonary unit is blocked when the balloon is inflated.

As used herein, the term “positive pressure ventilation” or “PPV” refersto the process of forcing air into the lungs of a patient.

As used herein, the term “pulmonary airway” refers to those parts of therespiratory system through which air flows, conceptually beginning (oninhalation from the external environment) at the nose and mouth, andterminating in the alveoli. From the mouth or nose, inhaled air passesthrough the pharynx into the trachea, where the air separates into theleft and right main bronchi at the carina, situated at the level of thesecond thoracic vertebra. The main bronchi then branch into largebronchioles, one for each lobe of the lung. Within the lobes, thebronchioles further subdivide some 20 times, ending in clusters ofalveoli.

As used herein, the term “tracheal intubation” refers to the placementof a flexible plastic tube into the trachea to protect the patient'sairway and provide a means of mechanical ventilation. The most commontracheal intubation is orotracheal intubation where, with the assistanceof a laryngoscope, an endotracheal tube is passed through the mouth,larynx, and vocal cords, into the trachea. Another possibility isnasotracheal intubation where a tube is passed through the nose, larynx,vocal cords, and trachea.

Disclosed herein are medical tubes for selective mechanical ventilationof the left lung or the right lung. FIG. 1 in conjunction with FIG. 2A,FIG. 2B and FIG. 3, show an embodiment of a single lumen endobronchialtube 100 of the present disclosure. The single lumen endobronchial tube100 is a medical tube that includes a proximal end 102, a distal end104, and a primary flow passage or lumen 160 passing therebetween. Thedistal end 104 of the tube 100 has a bronchial opening 140. In anembodiment, the bronchial opening 140 is smooth and beveled, thusminimizing risk of tracheal intubation airway trauma. The distal end 104of the tube 100 can optionally include a Murphy eye 142, which is adistal opening in a wall 110 and through an outer surface 101 of thetube 100 which can allow airflow in the event of the bronchial opening140 lying against the tracheal wall or being obstructed in other ways.Located at the proximal end 102 of the tube 100 is an opening 145sufficiently designed to connect with a mechanical ventilation device,including, but not limited to, an anesthesia machine or a PAP machine,with or without the use of an adaptor. The tube 100 includes a trachealportion 130 and a bronchial portion 150. The tube 100 may be made from aflexible material including, but not limited to, latex, silicone,polyvinyl chloride (PVC), polyurethane (PU), polytetrafluoroethylene ora similar material that has met the American National Standard forAnesthetic Equipment; ANSI Z-79 standard and implant-tested to ensurenontoxicity. In an embodiment, the tube 100 is made from a non-toxic,clear, PVC material. In an embodiment, the tracheal portion 130 isadapted to follow the natural contour of a patient's trachea, and thebronchial portion 150 is adapted to follow the natural contour of apatient's left main stem bronchi. In an embodiment, to facilitatepassage of the bronchial portion 150 into the left main stem bronchi,the tube 100 is curved or bent and resembles the shape of a hockeystick. In an embodiment, the angle of the bend is about 45°. The lumen160 of the tube 100 is sized and dimensioned to allow otherinstrumentation to pass through the lumen 160 as required. The removalof mucous, the injection of medication, or the insertion of fiberopticscopes for viewing within the tube 100 are examples of the additionalinstrumentation capability which is afforded by the tube 100. In anembodiment, the single lumen endobronchial tube 100 may be referred toas a left-sided single lumen endobronchial tube.

A tracheal cuff 132 and a bronchial cuff 152 are spaced longitudinallyalong an exterior surface of the tracheal portion 130 and the bronchialportion 150, respectively. In an embodiment, the tracheal cuff 132 andthe bronchial cuff 152 are thin walled, high volume low pressure (HVLP)balloon-like members sealed from fluid communication with the tube 100and adapted not to compromise the blood flow in the tracheal orbronchial wall when inflated. The tracheal cuff 132 and the bronchialcuff 152 are shown in an expanded state in FIG. 1. In an embodiment, theballoon-like members are spherical or elliptical in shape, although anydesired shape is possible and within the scope and spirit of the presentdisclosure. In an embodiment, the walls of the tracheal cuff 132 and thebronchial cuff 152 are on the order of about 5 μm to about 500 μm, about5 μm to about 250 μm, about 5 μm to about 100 μm, about 5 μm to about 50μm, about 5 μm and about 20 μm, about 5 μm and about 15 μm. It is alsocontemplated that the walls may have a thickness of less than about 5μm. Additionally, although the thickness of the walls may vary, it isdesirable that the thickness of the material remain consistentthroughout the cuff. A distal intraluminal balloon blocker 162 adaptedto inflate and deflate is positioned along an inner surface of the tube100 and when inflated acts to block flow by blocking ventilation to theleft main stem bronchus. In an embodiment, the distal intraluminalballoon blocker 162 is a low volume high pressure member. In anembodiment, the member is spherical or elliptical in shape, although anydesired shape is possible and within the scope and spirit of the presentdisclosure.

The tracheal cuff 132, the bronchial cuff 152, and the distalintraluminal balloon blocker 162 are each remotely and selectivelyinflatable through pilot tubes 232, 252 and 262, respectively, runninglongitudinally through the wall 110 of the tube 100 as shown in FIG. 3.The wall 110 has an internal wall surface, an external wall surface anda thickness therebetween. Each pilot tube 232, 252 and 262 emerges fromthe outer surface 101 of the tube 100 near the proximal end 102 of thetube 100. Attached to a proximal end of each pilot tube 232, 252 and 262is a non-return valve 230, 250 and 260 which is adapted to receive thenozzle of a syringe (not visible) and a complementary indicator bladder234, 254 and 264 which enables an anesthesiologist to confirm that eachof the tracheal cuff 132, the bronchial cuff 152, and the distalintraluminal balloon blocker 162 has been inflated or deflated. Thenon-return valves 230, 250 and 260 may be attached to a syringe forinjecting a predetermined quantity of air. Various materials may be usedto form the tracheal cuff 132, the bronchial cuff 152 and the distalintraluminal balloon blocker 162. These materials include, but are notlimited to, polyurethane (PU), low-density polyethylene (LDPE),polyvinyl chloride (PVC), silicone, neoprene, polyisoprene, polyamid(PA) or polyethylene teraphthalate (PETP). Additionally, copolymeradmixtures for modifying the characteristics of the material may beused, for example a low density polyethylene and ethylene-vinylacetatecopolymer (LDPE-EVA), or blends of the above mentioned materials (e.g.PU with PVC or PU with PA) would be considered suitable for forming thetracheal cuff 132, the bronchial cuff 152 and the distal intraluminalballoon blocker 162.

An aperture 170 is provided through the wall 110 of the tube 100 betweenthe tracheal cuff 132 and the bronchial cuff 152, as best illustrated inFIG. 1. The aperture 170 can be of any shape or size. In an embodiment,the aperture 170 is dimensioned so that a fiberoptic scope can passthrough the aperture 170. A shaft adapted to house components of amechanism, the components of the mechanism sufficiently designed to sealthe aperture 170, is created in the wall 110 of the tube 100. Variousembodiments of shafts and mechanism components are described in detailbelow. In the embodiments described in FIGS. 4-13 below, the shaft ismade up of two compartments, a chamber and a track housing. In theembodiments described in FIGS. 14-20 below, the shaft is made up of onecompartment, a track housing. The components of the mechanism areadapted to control the amount of medical gas passing through theaperture 170. In an embodiment, the components of the mechanism areadapted to completely close and seal the aperture 170 such that theamount of medical gas passing through the aperture 170 from the lumen160 is 0%. In an embodiment, the components of the mechanism are adaptedto partially close the aperture 170 such that the amount of medical gaspassing through the aperture 170 from the lumen 160 is greater than 0%but less than 100%. In an embodiment, the components of the mechanismfor controlling the flow of medical gas through the aperture 170 areremotely controlled through a pilot tube 272 running longitudinallythrough the wall 110 of the tube (see FIG. 3). The pilot tube 272emerges from the outer surface 101 near the proximal end 102 of the tube100. Attached to a proximal end of the pilot tube 272 is a non-returnvalve 270 which is adapted to receive the nozzle of a syringe (notvisible), and an indicator bladder 274 which enables an anesthesiologistto confirm that the mechanism has moved to close or seal the aperture170. The non-return valve 270 may be attached to a syringe for injectinga predetermined quantity of air, saline or any other fluid.

In some embodiments, the single lumen endobrochial tube is adapted foruse with a PAP machine. In such embodiments, conduits 282 and 292 (seeFIG. 3) run longitudinally through the wall 110 of the tube 100 todeliver gas to a patient at positive pressure in order to hold openalveoli that would normally close at the end of expiration. The tube 100can be manufactured to various sizes and adapted to provide mechanicalventilation to an air-breathing animal in need thereof. In anembodiment, the tube 100 is manufactured for human use and ranges insize from about 1.5 mm to about 11.0 mm in internal diameter (ID). In anembodiment, the tube 100 is manufactured for human use and ranges insize from about 3 mm to about 10 mm in internal diameter (ID). In anembodiment, the tube 100 is manufactured for non-human use and ranges insize from about 1.5 mm to about 40.0 mm in internal diameter (ID). In anembodiment, the tube 100 is manufactured for non-human use and ranges insize from about 6.0 mm to about 40.0 mm in internal diameter (ID).

Various embodiments of shafts and mechanism components adapted tocontrol the amount of medical gas passing through the aperture 170 willnow be discussed. The mechanism components disclosed herein are adaptedto partially or completely close the aperture 170 such that the amountof medical gas passing through the aperture 170 from the lumen 160ranges from about 0% to about 100%. In an embodiment, the aperture 170is fully closed and adapted to provide 100% of the medical gas toventilate the left lung (i.e., 0% of the medical gas ventilates theright lung). In an embodiment, the aperture 170 is fully open andadapted to provide 100% of the medical gas to ventilate the right lung(i.e., % of the medical gas ventilates the left lung). In an embodiment,the aperture 170 is partially open and adapted to provide about 50% ofthe medical gas to ventilate the left lung and about 50% of the medicalgas to ventilate the right lung. Such an embodiment can be beneficialduring the final stage of a medical procedure where a medicalpractitioner does not have to reposition the tube 100 to ventilate boththe left lung and the right lung. A mechanism of the present disclosureis controlled by a user of the tube 100, typically an anesthesiologist,such that selective ventilation of the left lung or the right lung isachievable without the need to move or reposition the tube 100. This ishighly beneficial to a patient, since postintubation repositioning of amedical tube can be highly dangerous.

FIG. 4 in conjunction with FIG. 5, FIG. 6 and FIG. 7 show an embodimentof a mechanism adapted to control the amount of medical gas passingthrough the aperture 170. The components of the mechanism are positionedwithin the wall 110 of the tube 100 such that the components are adaptedto move in a frontal plane parallel to the central longitudinal axis ofthe tube 100. An inner sealed diaphragm 340 is in fluid communicationwith the pilot tube 272 and separates a chamber 320 from the pilot tube272. A piston 300 having a base portion 362 engaging the diaphragm 340,and a rod portion 364 engaging a door portion 366, is powered by leafsprings 370 surrounding the rod portion 364, and is moveable along alongitudinal plane substantially parallel to a central longitudinal axisof the tube 100. By pushing fluid (such as air) through pilot tube 272,the diaphragm 340 is inflated (as illustrated in FIG. 6 and FIG. 7). Thebase portion 362 and the rod portion 364 of the piston 300 move withinthe chamber 320 and the door portion 366 moves within a track housing190. FIG. 8 shows a cross-sectional view taken along line 8-8 of FIG. 6.FIG. 9 shows a cross-sectional view taken along line 9-9 of FIG. 7. FIG.10 shows a cross-sectional plan view taken along line 10-10 of FIG. 4.

FIG. 11 shows a cutaway side view of an embodiment of a mechanismadapted to control the amount of medical gas passing through theaperture 170. The components of the mechanism are positioned within thewall 110 of the tube 100 such that the components are adapted to move inan axial plane perpendicular to the central longitudinal axis of thetube 100. An inner sealed diaphragm 440 is in fluid communication withthe pilot tube 272 and separates the chamber 320 from the pilot tube272. A piston having a base portion 462 engaging the diaphragm 440, anda rod portion 464 engaging a door portion 466, is powered by fluid(air), and leaf springs 470 surrounding the rod portion 464 bring thepiston back when the fluid pressure is off. The piston is moveable alonga plane substantially parallel to a central longitudinal axis of thetube 100. By pushing fluid (such as air) through pilot tube 272, thediaphragm 440 is inflated. The base portion 462 and the rod portion 464of the piston move within the chamber 320 and the door portion 466 moveswithin the track housing 190.

FIG. 12 shows a cutaway side view of an embodiment of a mechanismadapted to control the amount of medical gas passing through theaperture 170. The components of the mechanism are positioned within thewall 110 of the tube 100 such that the components are adapted to move ina frontal plane parallel to the central longitudinal axis of the tube100. An inner sealed diaphragm 540 is in fluid communication with thepilot tube 272 and separates a chamber 320 from the pilot tube 272. Apiston having a base portion 562 engaging the diaphragm 540, and a rodportion 564 engaging a door portion 566, is powered by fluid (air), andspring 570 surrounding the rod portion 564 bring the piston back whenthe fluid pressure is off. The piston is moveable along a longitudinalplane substantially parallel to a central longitudinal axis of the tube100. By pushing fluid (such as air) through pilot tube 272, thediaphragm 540 is inflated. The base portion 562 and the rod portion 564of the piston move within the chamber 320 and the door portion 566 moveswithin the track housing 190.

In an embodiment, the sealed diaphragm described in any of FIGS. 4-13 ismade of a flexible or stretchable elastomeric material, including, butnot limited to, silicone rubber. In an embodiment, the piston describedin any of FIGS. 4-13 is fabricated from a non-degradable biocompatiblenatural or synthetic polymer, a biocompatible flexible metal, orcombinations thereof. In an embodiment, the piston is manufactured froma polystyrene material. In an embodiment, the piston is manufacturedfrom a nitinol material. In an embodiment, the piston described in anyof FIGS. 4-13 is sufficiently shaped to follow the radius of curvatureof the tube 100 (see, for example, FIG. 5). In an embodiment, the sealeddiaphragm described in any of FIGS. 4-13, the piston described in any ofFIGS. 4-13, and the spring described in any of FIGS. 4-13 may befabricated from a disposable material and suitable for one-time use. Inan embodiment, the sealed diaphragm described in any of FIGS. 4-13, thepiston described in any of FIGS. 4-13, and the spring described in anyof FIGS. 4-13 may be fabricated from a sterilizable material andsuitable for re-use.

FIG. 14 in conjunction with FIG. 15 shows cutaway side views of anembodiment of mechanism adapted to control the amount of medical gaspassing through the aperture 170. The components of the mechanism arepositioned within the wall 110 of the tube 100 such that the componentsare adapted to move in a frontal plane parallel to the centrallongitudinal axis of the tube 100. A balloon (or inner sealed diaphragm)640 is in fluid communication with the pilot tube 272 and engages a doorportion 666 moveable within the track housing 190. In an embodiment, theballoon 640 is a low volume high pressure member. The door portion 666is controlled by pushing fluid (such as air) through pilot tube 272 toinflate the balloon 640 which moves the door portion 666 to cover theaperture 170 (FIG. 15). As illustrated in FIG. 14 and FIG. 15, the doorportion 666 is sufficiently shaped to follow the radius of curvature ofthe tube 100. As described above, the door portion 666 can be fabricatedfrom a non-degradable biocompatible natural or synthetic polymer, abiocompatible flexible metal, or combinations thereof. In an embodiment,the door portion 666 is manufactured from a polystyrene material. In anembodiment, the door portion 666 is manufactured from a nitinolmaterial. In an alternative embodiment, as illustrated in FIG. 16, awire 650 can be attached to the door portion 666 through the balloon 640to aid movement of the door portion 666. The wire 650 can bemanufactured from a host of materials, including, but not limited to,stainless steel, aluminum, copper, nickel, nitinol, teflon,polypropylene or similar material. Although the embodiments illustratedin FIG. 14 and FIG. 15 show the components adapted to move in a frontalplane parallel to the central longitudinal axis of the tube 100, itshould be understood that the components of the mechanism can bepositioned within the wall 110 of the tube 100 such that the componentsare adapted to move in an axial plane perpendicular to the centrallongitudinal axis of the tube 100, similar to what was illustrated inFIG. 11.

FIG. 17 in conjunction with FIG. 18 shows cutaway side views of anembodiment of mechanism adapted to control the amount of medical gaspassing through the aperture 170. The components of the mechanism arepositioned within the wall 110 of the tube 100 such that the componentsare adapted to move in a frontal plane parallel to the centrallongitudinal axis of the tube 100. A door portion 766 engages a firstwire 730 at a proximal end of the door portion 766, the first wire 730traveling through pilot tube 272 and exiting at the proximal end 102 ofthe tube 100; and also engages two wires at a distal end of the doorportion 766 that combine to form wire 740 traveling through channelsgenerally represented by 720 leading to pilot tube 272 and exiting atthe proximal end 102 of the tube 100. The door portion 766 is controlledby a user controlling the wires 730 and 740 at the proximal end 102 ofthe tube 100. In such an embodiment, the components labeled 270 and 274in FIG. 1, along with the tube leading into pilot tube 272, are notnecessary. The wire 730 moves within the pilot tube 272 and the twowires that combine to form wire 740 move within the channels generallyrepresented by 720. To move the door portion 766 from the restingposition in track housing 190 to over the aperture 170, wire 740 ispulled relative to wire 730. To move the door portion 766 so that thedoor portion 766 no longer covers the aperture 170, wire 730 is pulledrelative to wire 740. As illustrated in FIG. 17 and FIG. 18, the doorportion 766 is sufficiently shaped to follow the radius of curvature ofthe tube 100. As described above, the door portion 766 can be fabricatedfrom a non-degradable biocompatible natural or synthetic polymer, abiocompatible flexible metal, or combinations thereof. In an embodiment,the door portion 766 is manufactured from a polystyrene material. In anembodiment, the door portion 766 is manufactured from a nitinolmaterial. Although the embodiments illustrated in FIG. 17 and FIG. 18show the components adapted to move in a frontal plane parallel to thecentral longitudinal axis of the tube 100, it should be understood thatthe components of the mechanism can be positioned within the wall 110 ofthe tube 100 such that the components are adapted to move in an axialplane perpendicular to the central longitudinal axis of the tube 100,similar to what was illustrated in FIG. 11.

FIG. 19 shows an embodiment of a mechanism adapted to control the amountof medical gas passing through the aperture 170. The mechanism includesa first electromagnet 800 having a conductor (coiled wire 820) woundaround a core, a second electromagnet 850 having a conductor (coiledwire 870) wound around a core, and a door portion 866. As illustrated inFIG. 19, the door portion 866 includes ferrous metal plates 840 and 860that can either be added to the door portion 866 or built-in to the doorportion 866. The ferrous metal plates 840 and 860 can magneticallyengage the electromagnets 850 and 800. The electromagnets 850 and 800can be connected to an external current source (for example an AC or DCcurrent source) via wires 828 and 875 travelling through channelsrunning longitudinally through the wall 110 of the tube 100 to create amagnetic field capable of moving the door portion 866 to either coverthe aperture 170 or maintain the aperture 170 open, as illustrated inFIG. 19.

FIG. 20 shows an embodiment of a mechanism adapted to control the amountof medical gas passing through the aperture 170. The mechanism includesa door portion 966 having teeth 968, the teeth 968 engaging teeth 948 ofa rotatable shaft 940. A proximal end (not visible) of the shaft 940emerges from the proximal end 102 of the tube 100, where a user canrotate the shaft 940 causing the teeth 948 to catch the teeth 968 of thedoor portion 960, thus moving the door portion 960 as necessary tocontrol the amount of medical gas passing through the aperture 170.

FIG. 21 in conjunction with FIG. 22 shows cutaway side views of amechanism adapted to control the amount of medical gas passing throughthe aperture 170. The components of the mechanism are positioned withinthe wall 110 of the tube 100 such that the components are adapted tomove in a frontal plane parallel to the central longitudinal axis of thetube 100 to cover the aperture 170 when required. As illustrated in FIG.21, the mechanism includes a first expandable balloon 900 and a secondexpandable balloon 910 both in fluid communication with the pilot tube272 via tubes 272 a and 272 b, respectively. By pushing fluid (such asair) through pilot tube 272, and thus 272 a and 272 b, the firstexpandable balloon 900 and the second expandable balloon 910 areinflated (as illustrated in FIG. 22). In the embodiment illustrated inFIG. 21 and FIG. 22, when the balloons 900 and 910 are inflated, theballoons 900 and 910 expand from an outer boundary of the aperture 170towards the middle of the aperture 170 until they meet to substantiallycover the aperture 170 to prevent medical gas from escaping. In anembodiment, the first expandable balloon 900 and the second expandableballoon 910 are low volume high pressure members. In an embodiment, thefirst expandable balloon 900 and the second expandable balloon 910 arehigh volume low pressure members. Although not illustrated in FIG. 21and FIG. 22, in an embodiment, pilot tubes 272 a and 272 b eachseparately run longitudinally through the wall 110 of the tube so thateach of the balloons 900 and 910 can independently be expanded ordeflated.

FIG. 23 in conjunction with FIG. 24 shows cutaway side views of amechanism adapted to control the amount of medical gas passing throughthe aperture 170. The components of the mechanism are positioned withinthe wall 110 of the tube 100 such that the components are adapted tomove in a frontal plane parallel to the central longitudinal axis of thetube 100 to cover the aperture 170 when required. As illustrated in FIG.23, the mechanism includes a first expandable balloon 1000 and a secondexpandable balloon 1010 both in fluid communication with the pilot tube272 via tubes 272 a and 272 b, respectively. By pushing fluid (such asair) through pilot tube 272, and thus 272 a and 272 b, the firstexpandable balloon 1000 and the second expandable balloon 1010 areinflated (as illustrated in FIG. 24). In the embodiment illustrated inFIG. 23 and FIG. 24, when the balloons 1000 and 1010 are inflated, theballoons 1000 and 1010 expand from an outer boundary of the aperture 170towards the middle of the aperture 170 until they meet to substantiallycover the aperture 170 to prevent medical gas from escaping. In anembodiment, the first expandable balloon 1000 and the second expandableballoon 1010 are low volume high pressure members. In an embodiment, thefirst expandable balloon 1000 and the second expandable balloon 1010 arehigh volume low pressure members. Although not illustrated in FIG. 23and FIG. 24, in an embodiment, pilot tubes 272 a and 272 b eachseparately run longitudinally through the wall 110 of the tube so thateach of the balloons 1000 and 1010 can independently be expanded ordeflated.

FIG. 25 in conjunction with FIG. 26 shows cutaway side views of amechanism adapted to control the amount of medical gas passing throughthe aperture 170. The components of the mechanism are positioned withinthe wall 110 of the tube 100 such that the components are adapted tomove in a frontal plane parallel to the central longitudinal axis of thetube 100 to cover the aperture 170 when required. As illustrated in FIG.25, the mechanism includes an expandable balloon 1100 in fluidcommunication with the pilot tube 272. By pushing fluid (such as air)through pilot tube 272 the expandable balloon 1100 is inflated (asillustrated in FIG. 26). In the embodiment illustrated in FIG. 25 andFIG. 26, when the balloon 1100 is inflated, the balloon 1100 expandsfrom a first outer boundary of the aperture 170 towards a second outerboundary of the aperture 170 to substantially cover the aperture 170 toprevent medical gas from escaping. In an embodiment, the expandableballoon 1100 is a low volume high pressure member. In an embodiment, theexpandable balloon 1100 is a high volume low pressure member. Althoughthe embodiments illustrated in FIG. 25 and FIG. 26 show the balloon 1100positioned on the left outer boundary of the aperture 170, it should beunderstood that the balloon 1100 can be positioned on the right outerboundary of the aperture 170, the top outer boundary of the aperture 170or on the bottom outer boundary of the aperture 170 and still be withinthe scope and spirit of the present disclosure.

Referring to FIG. 27, the single lumen endobronchial tube 100 ispositioned within a patient to facilitate artificial ventilation of therespiratory system. The single lumen endobronchial tube 100 has beenplaced within a mouth of the patient and positioned such that thetracheal portion 130 resides within the trachea 1320 and the bronchialportion 150 resides within the left main stem bronchi 1330. The tube 100may be sufficiently designed such that the bronchial portion 150 curvesfor ease of placement beyond the carina 1340 into the left main stembronchi 1330. In this placement, ventilation of the left lung or theright lung can be accomplished without having to move the single lumenendobronchial tube. Placement of the single lumen endobronchial tube 100can be performed with or without fiberoptic visualization. Although FIG.27 shows the single lumen endobronchial tube 100 being inserted throughthe mouth of the patient, it should be understood that the single lumenendobronchial tube 100 can also be inserted through the nasal passagesinto the airway passage. For one-lung ventilation of the right lung1400, the aperture 170 remains open, which sufficiently allows the flowof medical gases through the aperture 170 and into the right lung. Onceproper positioning of the single lumen endobronchial tube 100 in thepulmonary airway is determined, the bronchial cuff 152 is inflated to adesired pressure by pushing a fluid such as air or saline through thepilot tube 252 leading to the bronchial cuff 152. In an embodiment, thebronchial cuff 152 is inflated so that the bronchial cuff pressure (BCP)is in the range of about 15 cm H₂O (about 11 mm Hg) to about 30 cm H₂O(about 22 mm Hg). The tracheal cuff 132 is inflated by pushing a fluidsuch as air or saline through the pilot tube 232 leading to the trachealcuff 132. In an embodiment, the tracheal cuff 132 is inflated so thatthe cuff pressure is in the range of about 15 cm H₂O (about 11 mm Hg) toabout 30 cm H₂O (about 22 mm Hg). The seal formed by the tracheal cuff132 is adapted to substantially provide a seal between the outside ofthe single lumen endobronchial tube 100 and the interior of the trachea1320 in which the single lumen endobronchial tube 100 is inserted. Thedistal intraluminal balloon blocker 162 is inflated by pushing a fluidsuch as air or saline through the pilot tube 262 leading to the distalintraluminal balloon blocker 162. In an embodiment, the distalintraluminal balloon blocker 162 is inflated so that the cuff pressureis in the range of about 20 cm H₂O (about 14.7 mm Hg) to about 95 cm H₂O(about 69 mm Hg). The desired agent(s) are then introduced, for examplefrom an anesthesia machine, through the lumen 160 of the tube 100 todeliver the desired agent(s) to the right lung 1400. The inflated distalintraluminal balloon blocker seals the lumen 160 of the tube 100 distalto the inflated distal intraluminal balloon blocker 162 such thatsufficient blockage of the agents to the left lung 1300 is achieved.

FIG. 28 shows the single lumen endobronchial tube 100 positioned duringone-lung ventilation of the left lung 1300. The single lumenendobronchial tube 100 is placed in the pulmonary airway of a patientsuch that the tracheal portion 130 resides within the trachea 1320 andthe bronchial portion 150 resides within the left main stem bronchi1330. The tube 100 may be sufficiently designed such that the bronchialportion 150 curves for ease of placement beyond the carina 1340 into theleft main stem bronchi 1330. Placement of the single lumen endobronchialtube 100 can be performed with or without fiberoptic visualization. Forone-lung ventilation of the left lung, the aperture 170 is sealed tosufficiently preclude the flow of medical gases through the aperture 170and into the right lung. Once proper positioning of the single lumenendobronchial tube 100 in the pulmonary airway is determined, thebronchial cuff 152 is inflated to a desired pressure by pushing a fluidsuch as air or saline through the pilot tube 252 leading to thebronchial cuff 152. In an embodiment, the bronchial cuff 152 is inflatedso that the cuff pressure is in the range of about 15 cm H₂O (about 11mm Hg) to about 30 cm H₂O (about 22 mm Hg). The seal formed by thebronchial cuff 152 is adapted to preclude any medical gas that has beenforced into the patient's left lung from escaping through the left mainstem bronchi 1330 into the trachea 1320. The tracheal cuff 132 isinflated by pushing a fluid such as air or saline through the pilot tube232 leading to the tracheal cuff 132. In an embodiment, the trachealcuff 132 is inflated so that the bronchial cuff pressure (BCP) is in therange of about 15 cm H₂O (about 11 mm Hg) to about 30 cm H₂O (about 22mm Hg). The seal formed by the tracheal cuff 132 is adapted tosubstantially provide a seal between the outside of the single lumenendobronchial tube 100 and the interior of the trachea 1320 in which thesingle lumen endobronchial tube 100 is inserted. The desired agent(s)are then introduced, for example from an anesthesia machine, through thelumen 160 of the tube 100 to deliver the desired agent(s) to the leftlung 1300.

It is also contemplated that in an alternative embodiment of the singlelumen endobronchial tube, the distal intraluminal balloon blocker 162(as well as the other co-dependent components of the distal intraluminalballoon blocker 162 including the pilot tube 262, the non-return valve260 and the pilot balloon 264) are absent. In such an embodiment, aconventional endobronchial blocker can be used to block ventilation ofthe left main stem bronchi.

FIG. 29 shows an embodiment of a single lumen endobronchial tube 2100 ofthe present disclosure. The single lumen endobronchial tube 2100 is amedical tube having a proximal end 2102, a distal end 2104, and aprimary flow passage or lumen 2160 passing therebetween. The distal end2104 of the tube 2100 has a bronchial opening 2140. In an embodiment,the bronchial opening 2140 is smooth and beveled, thus minimizing riskof tracheal intubation airway trauma. The distal end 2104 of the tube2100 can optionally include a Murphy eye 2142, which is a distal openingin a wall 2110 and through an outer surface 2101 of the tube 2100 whichcan allow airflow in the event of the bronchial opening 2140 lyingagainst the tracheal wall or being obstructed in other ways. Located atthe proximal end 2102 of the tube 2100 is an opening 2145 sufficientlydesigned to connect with a mechanical ventilation device, including, butnot limited to, an anesthesia machine or a PAP machine, with or withoutthe use of an adaptor. The tube 2100 includes a tracheal portion 2130and a bronchial portion 2150. The tube 2100 may be made from a flexiblematerial including, but not limited to, latex, silicone, polyvinylchloride (PVC), polyurethane (PU), polytetrafluoroethylene or a similarmaterial that has met the American National Standard for AnestheticEquipment; ANSI Z-79 standard and implant-tested to ensure nontoxicity.In an embodiment, the tube 2100 is made from a non-toxic, clear, PVCmaterial. In an embodiment, the tracheal portion 2130 is adapted tofollow the natural contour of a patient's trachea, and the bronchialportion 2150 is adapted to follow the natural contour of a patient'sleft main stem bronchi. In an embodiment, to facilitate passage of thebronchial portion 2150 into the left main stem bronchi, the tube 2100 iscurved or bent and resembles the shape of a hockey stick. In anembodiment, the angle of the bend is about 45°. The lumen 2160 of thetube 2100 is sized and dimensioned to allow other instrumentation topass through the lumen 2160 as required. The removal of mucous, theinjection of medication, or the insertion of fiberoptic scopes forviewing within the tube 2100 are examples of the additionalinstrumentation capability which is afforded by the tube 2100. In anembodiment, the single lumen endobronchial tube 2100 may be referred toas a left-sided single lumen endobronchial tube.

A first tracheal cuff 2132, a second tracheal cuff 2172 and a bronchialcuff 2152 are spaced longitudinally along an exterior surface of thetracheal portion 2130 and the bronchial portion 2150, respectively. Inan embodiment, the first tracheal cuff 2132, the second tracheal cuff2172 and the bronchial cuff 2152 are thin walled, high volume lowpressure (HVLP) balloon-like members sealed from fluid communicationwith the tube 2100 and adapted not to compromise the blood flow in thetracheal or bronchial wall when inflated. The first tracheal cuff 2132,the second tracheal cuff 2172, and the bronchial cuff 2152 are shown inan expanded state in FIG. 29. In an embodiment, the balloon-like membersare spherical or elliptical in shape, although any desired shape ispossible and within the scope and spirit of the present disclosure. Inan embodiment, the walls of the first tracheal cuff 2132, the secondtracheal cuff 2172 and the bronchial cuff 2152 are on the order of about5 μm to about 500 μm, about 5 μm to about 250 μm, about 5 μm to about100 μm, about 5 μm to about 50 μm, about 5 μm and about 20 μm, about 5μm and about 15 μm. It is also contemplated that the walls may have athickness of less than about 5 μm. Additionally, although the thicknessof the walls may vary, it is desirable that the thickness of thematerial remain consistent throughout the cuff. A distal intraluminalballoon blocker 2162 adapted to inflate and deflate is positioned alongan inner surface of the tube 2100 and when inflated acts to block flowby blocking ventilation to the left main stem bronchus. In anembodiment, the distal intraluminal balloon blocker 2162 is a low volumehigh pressure member. In an embodiment, the member is spherical orelliptical in shape, although any desired shape is possible and withinthe scope and spirit of the present disclosure.

The first tracheal cuff 2132, the second tracheal cuff 2172, thebronchial cuff 2152, and the distal intraluminal balloon blocker 2162are each remotely and selectively inflatable through pilot tubes 2232,2172, 2252 and 2262, respectively, running longitudinally through thewall of the tube 2100. The wall has an internal wall surface, anexternal wall surface and a thickness therebetween. Each pilot tube2232, 2172, 2252 and 2262 emerges from the outer surface 2101 of thetube 2100 near the proximal end 2102 of the tube 2100. Attached to aproximal end of each pilot tube 2232, 2172, 2252 and 2262 is anon-return valve 2230, 2270, 2250 and 2260 which is adapted to receivethe nozzle of a syringe (not visible) and a complementary indicatorbladder 2234, 2274, 2254 and 2264 which enables an anesthesiologist toconfirm that each of the first tracheal cuff 2132, the second trachealcuff 2172, the bronchial cuff 2152, and the distal intraluminal balloonblocker 2162 has been inflated or deflated. The non-return valves 2230,2270, 2250 and 2260 may be attached to a syringe for injecting apredetermined quantity of air. Various materials may be used to form thefirst tracheal cuff 2132, the second tracheal cuff 2172, the bronchialcuff 2152 and the distal intraluminal balloon blocker 2162. Thesematerials include, but are not limited to, polyurethane (PU),low-density polyethylene (LDPE), polyvinyl chloride (PVC), silicone,neoprene, polyisoprene, polyamid (PA) or polyethylene teraphthalate(PETP). Additionally, copolymer admixtures for modifying thecharacteristics of the material may be used, for example a low densitypolyethylene and ethylene-vinylacetate copolymer (LDPE-EVA), or blendsof the above mentioned materials (e.g. PU with PVC or PU with PA) wouldbe considered suitable for forming the first tracheal cuff 2132, thesecond tracheal cuff 2172, the bronchial cuff 2152 and the distalintraluminal balloon blocker 2162.

An aperture 2170 is provided through the wall 2110 of the tube 2100between the first tracheal cuff 2132 and the second tracheal cuff 2172.The aperture 2170 can be of any shape or size. In an embodiment, theaperture 2170 is dimensioned so that a fiberoptic scope can pass throughthe aperture 2170. In some embodiments, the single lumen endobrochialtube is adapted for use with a PAP machine. In such embodiments,conduits run longitudinally through the wall 2110 of the tube 2100 todeliver gas to a patient at positive pressure in order to hold openalveoli that would normally close at the end of expiration. The tube2100 can be manufactured to various sizes and adapted to providemechanical ventilation to an air-breathing animal in need thereof. In anembodiment, the tube 2100 is manufactured for human use and ranges insize from about 1.5 mm to about 11 mm in internal diameter (ID). In anembodiment, the tube 2100 is manufactured for human use and ranges insize from about 3 mm to about 10 mm in internal diameter (ID). In anembodiment, the tube 2100 is manufactured for non-human use and rangesin size from about 1.5 mm to about 40 mm in internal diameter (ID). Inan embodiment, the tube 2100 is manufactured for non-human use andranges in size from about 6 mm to about 40 mm in internal diameter (ID).

Referring to FIG. 30, the single lumen endobronchial tube 2100 ispositioned within a patient to facilitate artificial ventilation of therespiratory system. The single lumen endobronchial tube 2100 has beenplaced within a mouth of the patient and positioned such that thetracheal portion 2130 resides within the trachea 1320 and the bronchialportion 2150 resides within the left main stem bronchi 1330. The tube2100 may be sufficiently designed such that the bronchial portion 2150curves for ease of placement beyond the carina 1340 into the left mainstem bronchi 1330. In this placement, ventilation of the left lung orthe right lung can be accomplished without having to move the lumenendobronchial tube. Placement of the lumen endobronchial tube can beperformed with or without fiberoptic visualization. Although FIG. 30shows the lumen endobronchial tube being inserted through the mouth ofthe patient, it should be understood that the lumen endobronchial tubecan also be inserted through the nasal passages into the airway passage.Once proper positioning of the lumen endobronchial tube in the pulmonaryairway is determined, the bronchial cuff 2152 is inflated to a desiredpressure by pushing a fluid such as air or saline through the pilot tube2252 leading to the bronchial cuff 2152. In an embodiment, the bronchialcuff 2152 is inflated so that the bronchial cuff pressure (BCP) is inthe range of about 15 cm H₂O (about 11 mm Hg) to about 30 cm H₂O (about22 mm Hg). The first tracheal cuff 2132 is inflated by pushing a fluidsuch as air or saline through the pilot tube 2232 leading to the firsttracheal cuff 2132. The second tracheal cuff 2172 is inflated by pushinga fluid such as air or saline through the pilot tube 2272 leading to thesecond tracheal cuff 2172. In an embodiment, the first tracheal cuff2132 and the second tracheal cuff 2172 are inflated so that the cuffpressure is in the range of about 15 cm H₂O (about 11 mm Hg) to about 30cm H₂O (about 22 mm Hg). The seal formed by the tracheal cuffs 2132 and2172 are adapted to substantially provide a seal between the outside ofthe lumen endobronchial tube and the interior of the trachea 1320 inwhich the tube 2100 is inserted. The desired agent(s) are thenintroduced, for example from an anesthesia machine, through the lumen2160 of the tube 2100 to deliver the desired agent(s) to the left lung1300. The closed space between the first tracheal cuff 2132 and thesecond tracheal cuff 2172 is adapted to block entry of the desiredagent(s) to the right lung 1400. If the desired agent(s) are to bedelivered into the right lung 1400 and not the left lung 1300, theprocedure can proceed as follows: the second tracheal cuff 2172 isdeflated, and the distal intraluminal balloon blocker 2162 is inflatedby pushing a fluid such as air or saline through the pilot tube 2262leading to the distal intraluminal balloon blocker 2162. In anembodiment, the distal intraluminal balloon blocker 2162 is inflated sothat the cuff pressure is in the range of about 20 cm H₂O (about 14.7 mmHg) to about 95 cm H₂O (about 69 mm Hg). The inflated distalintraluminal balloon blocker seals the lumen 2160 of the tube 2100distal to the inflated distal intraluminal balloon blocker 2162 suchthat sufficient blockage of the agents to the left lung 1300 isachieved.

It is also contemplated that in an alternative embodiment of the singlelumen endobronchial tube, the distal intraluminal balloon blocker 2162(as well as the other co-dependent components of the distal intraluminalballoon blocker 2162 including the pilot tube 2262, the non-return valve2260 and the pilot balloon 2264) are absent. In such an embodiment, aconventional endobronchial blocker can be used to block ventilation ofthe left main stem bronchi.

FIG. 31 shows an embodiment of a single lumen endobronchial tube 3100 ofthe present disclosure. The single lumen endobronchial tube 3100 is amedical tube having a proximal end 3102, a distal end 3104, and aprimary flow passage or lumen 3160 passing therebetween. The distal end3104 of the tube 3100 has a bronchial opening 3140. In an embodiment,the bronchial opening 3140 is smooth and beveled, thus minimizing riskof tracheal intubation airway trauma. The distal end 3104 of the tube3100 can optionally include a Murphy eye 3142, which is a distal openingin a wall 3110 and through an outer surface 3101 of the tube 3100 whichcan allow airflow in the event of the bronchial opening 3140 lyingagainst the tracheal wall or being obstructed in other ways. Located atthe proximal end 3102 of the tube 3100 is an opening 3145 sufficientlydesigned to connect with a mechanical ventilation device, including, butnot limited to, an anesthesia machine or a PAP machine, with or withoutthe use of an adaptor. The tube 3100 includes a tracheal portion 3130and a bronchial portion 3150. The tube 3100 may be made from a flexiblematerial including, but not limited to, latex, silicone, polyvinylchloride (PVC), polyurethane (PU), polytetrafluoroethylene or a similarmaterial that has met the American National Standard for AnestheticEquipment; ANSI Z-79 standard and implant-tested to ensure nontoxicity.In an embodiment, the tube 3100 is made from a non-toxic, clear, PVCmaterial. In an embodiment, the tracheal portion 3130 is adapted tofollow the natural contour of a patient's trachea, and the bronchialportion 3150 is adapted to follow the natural contour of a patient'sleft main stem bronchi. In an embodiment, to facilitate passage of thebronchial portion 150 into the left main stem bronchi, the tube 3100 iscurved or bent and resembles the shape of a hockey stick. In anembodiment, the angle of the bend is about 45°. The lumen 3160 of thetube 3100 is sized and dimensioned to allow other instrumentation topass through the lumen 3160 as required. The removal of mucous, theinjection of medication, or the insertion of fiberoptic scopes forviewing within the tube 3100 are examples of the additionalinstrumentation capability which is afforded by the tube 3100. In anembodiment, the single lumen endobronchial tube 3100 may be referred toas a left-sided single lumen endobronchial tube.

A tracheal cuff 3132 and a bronchial cuff 3152 are spaced longitudinallyalong an exterior surface of the tracheal portion 3130 and the bronchialportion 3150, respectively. In an embodiment, the tracheal cuff 3132 andthe bronchial cuff 3152 are thin walled, high volume low pressure (HVLP)balloon-like members sealed from fluid communication with the tube 3100and adapted not to compromise the blood flow in the tracheal orbronchial wall when inflated. The tracheal cuff 3132 and the bronchialcuff 3152 are shown in an expanded state in FIG. 31. In an embodiment,the balloon-like members are spherical or elliptical in shape, althoughany desired shape is possible and within the scope and spirit of thepresent disclosure. In an embodiment, the walls of the tracheal cuff3132 and the bronchial cuff 3152 are on the order of about 5 μm to about500 μm, about 5 μm to about 250 μm, about 5 μm to about 100 μm, about 5μm to about 50 μm, about 5 μm and about 20 μm, about 5 μm and about 15μm. It is also contemplated that the walls may have a thickness of lessthan about 5 μm. Additionally, although the thickness of the walls mayvary, it is desirable that the thickness of the material remainconsistent throughout the cuff. A distal intraluminal balloon blocker3162 adapted to inflate and deflate is positioned along an inner surfaceof the tube 3100 and when inflated acts to block flow by blockingventilation to the left main stem bronchus. In an embodiment, the distalintraluminal balloon blocker 3162 is a low volume high pressure member.In an embodiment, the member is spherical or elliptical in shape,although any desired shape is possible and within the scope and spiritof the present disclosure.

The tracheal cuff 3132, the bronchial cuff 3152, and the distalintraluminal balloon blocker 3162 are each remotely and selectivelyinflatable through pilot tubes 3232, 3252 and 3262, respectively,running longitudinally through the wall 3110 of the tube 3100. The wall3110 has an internal wall surface, an external wall surface and athickness therebetween. Each pilot tube 3232, 3252 and 3262 emerges fromthe outer surface 3101 of the tube 3100 near the proximal end 3102 ofthe tube 3100. Attached to a proximal end of each pilot tube 3232, 3252and 3262 is a non-return valve 3230, 3250 and 3260 which is adapted toreceive the nozzle of a syringe (not visible) and a complementaryindicator bladder 3234, 3254 and 3264 which enables an anesthesiologistto confirm that each of the tracheal cuff 3132, the bronchial cuff 3152,and the distal intraluminal balloon blocker 3162 has been inflated ordeflated. The non-return valves 3230, 3250 and 3260 may be attached to asyringe for injecting a predetermined quantity of air. Various materialsmay be used to form the tracheal cuff 3132, the bronchial cuff 3152 andthe distal intraluminal balloon blocker 3162. These materials include,but are not limited to, polyurethane (PU), low-density polyethylene(LDPE), polyvinyl chloride (PVC), silicone, neoprene, polyisoprene,polyamid (PA) or polyethylene teraphthalate (PETP). Additionally,copolymer admixtures for modifying the characteristics of the materialmay be used, for example a low density polyethylene andethylene-vinylacetate copolymer (LDPE-EVA), or blends of the abovementioned materials (e.g. PU with PVC or PU with PA) would be consideredsuitable for forming the tracheal cuff 3132, the bronchial cuff 3152 andthe distal intraluminal balloon blocker 3162. It is also contemplatedthat in an alternative embodiment of the single lumen endobronchialtube, the distal intraluminal balloon blocker 3162 (as well as the otherco-dependent components of the distal intraluminal balloon blocker 3162including the pilot tube 3262, the non-return valve 3260 and the pilotballoon 3264) are absent. In such an embodiment, a conventionalendobronchial blocker can be used to block ventilation of the left mainstem bronchi.

An aperture 3170 is provided through the wall 3110 of the tube 3100between the tracheal cuff 3132 and the bronchial cuff 3152. The aperture3170 can be of any shape or size. In an embodiment, the aperture 3170 isdimensioned so that a fiberoptic scope can pass through the aperture3170. An expandable balloon 3400 is sufficiently designed to seal theaperture 3170. The expandable balloon 3400 is adapted to control theamount of medical gas passing through the aperture 3170. In anembodiment, the expandable balloon 3400 is adapted to completely closeand seal the aperture 3170 such that the amount of medical gas passingthrough the aperture 3170 from the lumen 3160 is 0%. The expandableballoon 3400 is shown in an expanded state in FIG. 31. As illustrated inFIG. 32, which is a cross-sectional plan view taken along line 32-32 ofFIG. 31, when the expandable balloon 3400 is inflated, the expandableballoon 3400 is sufficiently designed to seal up against a trachea andthe pressure inside the expandable balloon 3400 keeps the aperture 3170closed. The expandable balloon 3400 closes the aperture 3170 yet doesnot herniate into the lumen 3160 of the tube 3100. If the expandableballoon 3400 inflates from the distal border of the aperture 3170 (asillustrated in FIG. 34) conceivably any air leakage from the aperture3170 would get trapped in a tracheal space formed by the tracheal cuff3132 and the expandable balloon 3400. In an embodiment, the expandableballoon 3400 is a thin walled, high volume low pressure (HVLP) membersealed from fluid communication with the tube 3100 and adapted not tocompromise the blood flow in the tracheal or bronchial wall wheninflated. In an embodiment, the expandable balloon 3400 is spherical orelliptical in shape, although any desired shape is possible and withinthe scope and spirit of the present disclosure. In an embodiment, thewalls of the expandable balloon 3400 are on the order of about 5 μm toabout 500 μm, about 5 μm to about 250 μm, about 5 μm to about 100 μm,about 5 μm to about 50 μm, about 5 μm and about 20 μm, about 5 μm andabout 15 μm. It is also contemplated that the walls may have a thicknessof less than about 5 μm. Additionally, although the thickness of thewalls may vary, it is desirable that the thickness of the materialremain consistent throughout the cuff. In an embodiment, the expandableballoon 3400 is remotely controlled through a pilot tube 3272 runninglongitudinally through the wall 3110 of the tube (see FIG. 32). Thepilot tube 3272 emerges from the outer surface 3101 near the proximalend 3102 of the tube 3100. Attached to a proximal end of the pilot tube3272 is a non-return valve 3270 which is adapted to receive the nozzleof a syringe (not visible), and an indicator bladder 3274 which enablesan anesthesiologist to confirm that the expandable balloon 3400 has beeninflated to close or seal the aperture 3170. The non-return valve 3270may be attached to a syringe for injecting a predetermined quantity ofair, saline or any other fluid.

In some embodiments, the single lumen endobrochial tube is adapted foruse with a PAP machine. In such embodiments, conduits run longitudinallythrough the wall 3110 of the tube 3100 to deliver gas to a patient atpositive pressure in order to hold open alveoli that would normallyclose at the end of expiration. The tube 3100 can be manufactured tovarious sizes and adapted to provide mechanical ventilation to anair-breathing animal in need thereof. In an embodiment, the tube 3100 ismanufactured for human use and ranges in size from about 1.5 mm to about11 mm in internal diameter (ID). In an embodiment, the tube 3100 ismanufactured for human use and ranges in size from about 3 mm to about10 mm in internal diameter (ID). In an embodiment, the tube 3100 ismanufactured for non-human use and ranges in size from about 1.5 mm toabout 40 mm in internal diameter (ID). In an embodiment, the tube 3100is manufactured for non-human use and ranges in size from about 6 mm toabout 40 mm in internal diameter (ID).

FIG. 33 in conjunction with FIG. 34 shows cutaway side views of theexpandable balloon 3400 adapted to control the amount of medical gaspassing through the aperture 3170. As illustrated in FIG. 33, theexpandable balloon 3400 is in fluid communication with the pilot tube3272. By pushing fluid (such as air) through pilot tube 3272 theexpandable balloon 3400 is inflated (as illustrated in FIG. 34). Whenthe expandable balloon 3400 is inflated, the expandable balloon 3400seals up against the trachea and the pressure keeps the aperture 3170closed. The expandable balloon 3400 closes the aperture 3170 yet doesnot herniate into the lumen 3160 of the tube 3100. If the expandableballoon 3400 inflates from the distal border of the aperture 3170 (asillustrated in FIG. 34) conceivably any air leakage from the aperture3170 would get trapped in a tracheal space formed by the tracheal cuff3132 and the expandable balloon 3400. Although the embodimentsillustrated in FIG. 33 and FIG. 34 show the expandable balloon 3400positioned on the bottom outer boundary of the aperture 3170, it shouldbe understood that the balloon 3400 can be positioned on the right outerboundary of the aperture 3170, the top outer boundary of the aperture3170 or on the left outer boundary of the aperture 3170 and still bewithin the scope and spirit of the present disclosure.

Referring to FIG. 35, the single lumen endobronchial tube 3100 ispositioned within a patient to facilitate artificial ventilation of therespiratory system. The single lumen endobronchial tube 3100 has beenplaced within a mouth of the patient and positioned such that thetracheal portion 3130 resides within the trachea 1320 and the bronchialportion 3150 resides within the left main stem bronchi 1330. The tube3100 may be sufficiently designed such that the bronchial portion 3150curves for ease of placement beyond the carina 1340 into the left mainstem bronchi 1330. In this placement, ventilation of the left lung orthe right lung can be accomplished without having to move the tube 3100.Placement of the single lumen endobronchial tube 3100 can be performedwith or without fiberoptic visualization. Although FIG. 35 shows thesingle lumen endobronchial tube 3100 being inserted through the mouth ofthe patient, it should be understood that the single lumen endobronchialtube 3100 can also be inserted through the nasal passages into theairway passage. Once proper positioning of the single lumenendobronchial tube 3100 in the pulmonary airway is determined, thebronchial cuff 3152 is inflated to a desired pressure by pushing a fluidsuch as air or saline through the pilot tube 3252 leading to thebronchial cuff 3152. In an embodiment, the bronchial cuff 3152 isinflated so that the bronchial cuff pressure (BCP) is in the range ofabout 15 cm H₂O (about 11 mm Hg) to about 30 cm H₂O (about 22 mm Hg).The tracheal cuff 3132 is inflated by pushing a fluid such as air orsaline through the pilot tube 3232 leading to the tracheal cuff 3132. Inan embodiment, the tracheal cuff 3132 is inflated so that the cuffpressure is in the range of about 15 cm H₂O (about 11 mm Hg) to about 30cm H₂O (about 22 mm Hg). The seal formed by the tracheal cuff 3132 isadapted to substantially provide a seal between the outside of the tube3100 and the interior of the trachea 1320 in which the tube 3100 isinserted. The expandable balloon 3400 is inflated by pushing a fluidsuch as air or saline through the pilot tube 3272 leading to theexpandable balloon 3400. When the expandable balloon 3400 is inflated,the expandable balloon 3400 seals up against the trachea 1320 and thepressure keeps the aperture 3170 closed. In an embodiment, theexpandable balloon 3400 closes the aperture 3170 without herniating intothe lumen 3160 of the tube 3100. When the expandable balloon 3400inflates from the distal border of the aperture 3170 (as illustrated inFIG. 34) any air that may leak from the aperture 3170 would get trappedin a tracheal space formed by the tracheal cuff 3132 and the expandableballoon 3400. The desired agent(s) are then introduced, for example froman anesthesia machine, through the lumen 3160 of the tube 3100 todeliver the desired agent(s) to the left lung 1300. The closed spacebetween the tracheal cuff 3132 and the expandable balloon 3400 isadapted to block entry of the desired agent(s) to the right lung 1400.If the desired agent(s) are to be delivered into the right lung 1400 andnot the left lung 1300, the procedure can proceed as follows: theexpandable balloon 3400 is deflated, and the distal intraluminal balloonblocker 3162 is inflated by pushing a fluid such as air or salinethrough the pilot tube 3262 leading to the distal intraluminal balloonblocker 3162. In an embodiment, the distal intraluminal balloon blocker3162 is inflated so that the cuff pressure is in the range of about 20cm H₂O (about 14.7 mm Hg) to about 95 cm H₂O (about 69 mm Hg). Theinflated distal intraluminal balloon blocker seals the lumen 3160 of thetube 3100 distal to the inflated distal intraluminal balloon blocker3162 such that sufficient blockage of the agents to the left lung 1300is achieved.

Endobronchial tube displacement may result in life-threateningcomplications and continuous direct vision of the position of theendobronchial tube may enable safer management. In an embodiment, any ofthe single lumen endobronchial tubes disclosed herein may furtherinclude a built-in video camera having an optional built-in lightsource. The video camera is connected to a monitor via a cable that runslongitudinally through the wall of the tube. The video camera and cableare embedded within the common tube wall. In an embodiment, the viewfrom the video camera appears continuously on the monitor in theanaesthetist's vicinity. In an embodiment, the video camera terminatesat a location that is distal to the aperture that is provided throughthe wall of the tube between the tracheal balloon cuff and the bronchialballoon cuff. The placement of the video camera at this location mayprovide for a better view of the carina of the trachea, thecartilaginous ridge within the trachea that runs anteroposteriorlybetween the two primary bronchi at the site of the tracheal bifurcationat the lower end of the trachea. This may help ensure that the bronchialportion of the single lumen endobronchial tube is positioned below thecarina. In embodiments where the single lumen endobronchial tubeincludes a built-in video camera, it may not be necessary to use afiberoptic scope during placement, use, or removal of the tube.

FIG. 36 in conjunction with FIG. 37 shows an embodiment of a singlelumen endobronchial tube 4100 of the present disclosure. The singlelumen endobronchial tube 4100 is a medical tube that includes a built-invideo camera 4300 having an optional built-in light source. The videocamera 4300 is connected to a monitor 4350 via a cable 4332 that runslongitudinally through the wall 4110 of the tube 4100. The video camera4300 and cable 4332 are embedded within the common tube wall 4110. In anembodiment, the view from the video camera 4300 appears continuously onthe monitor 4350 in the anaesthetist's vicinity. The single lumenendobronchial tube 4100 has a proximal end 4102, a distal end 4104, anda primary flow passage or lumen 4160 passing therebetween. The distalend 4104 of the tube 4100 has a bronchial opening 4140. In anembodiment, the bronchial opening 4140 is smooth and beveled, thusminimizing risk of tracheal intubation airway trauma. The distal end4104 of the tube 4100 can optionally include a Murphy eye 4142, which isa distal opening in a wall 4110 and through an outer surface 4101 of thetube 4100 which can allow airflow in the event of the bronchial opening4140 lying against the tracheal wall or being obstructed in other ways.Located at the proximal end 4102 of the tube 4100 is an opening 4145sufficiently designed to connect with a mechanical ventilation device,including, but not limited to, an anesthesia machine or a PAP machine,with or without the use of an adaptor. The tube 4100 includes a trachealportion 4130 and a bronchial portion 4150. The tube 4100 may be madefrom a flexible material including, but not limited to, latex, silicone,polyvinyl chloride (PVC), polyurethane (PU), polytetrafluoroethylene ora similar material that has met the American National Standard forAnesthetic Equipment; ANSI Z-79 standard and implant-tested to ensurenontoxicity. In an embodiment, the tube 4100 is made from a non-toxic,clear, PVC material. In an embodiment, the tracheal portion 4130 isadapted to follow the natural contour of a patient's trachea, and thebronchial portion 4150 is adapted to follow the natural contour of apatient's left main stem bronchi. In an embodiment, to facilitatepassage of the bronchial portion 4150 into the left main stem bronchi,the tube 4100 is curved or bent and resembles the shape of a hockeystick. In an embodiment, the angle of the bend is about 45°. The lumen4160 of the tube 4100 is sized and dimensioned to allow otherinstrumentation to pass through the lumen 4160 as required. The removalof mucous, the injection of medication, or the insertion of fiberopticscopes for viewing within the tube 4100 are examples of the additionalinstrumentation capability which is afforded by the tube 4100. In anembodiment, the single lumen endobronchial tube 4100 may be referred toas a left-sided single lumen endobronchial tube.

A tracheal cuff 4132 and a bronchial cuff 4152 are spaced longitudinallyalong an exterior surface of the tracheal portion 4130 and the bronchialportion 4150, respectively. In an embodiment, the tracheal cuff 4132 andthe bronchial cuff 4152 are thin walled, high volume low pressure (HVLP)balloon-like members sealed from fluid communication with the tube 4100and adapted not to compromise the blood flow in the tracheal orbronchial wall when inflated. The tracheal cuff 4132 and the bronchialcuff 4152 are shown in an expanded state in FIG. 36. In an embodiment,the balloon-like members are spherical or elliptical in shape, althoughany desired shape is possible and within the scope and spirit of thepresent disclosure. In an embodiment, the walls of the tracheal cuff4132 and the bronchial cuff 4152 are on the order of about 5 μm to about500 μm, about 5 μm to about 250 μm, about 5 μm to about 100 μm, about 5μm to about 50 μm, about 5 μm and about 20 μm, about 5 μm and about 15μm. It is also contemplated that the walls may have a thickness of lessthan about 5 μm. Additionally, although the thickness of the walls mayvary, it is desirable that the thickness of the material remainconsistent throughout the cuff. A distal intraluminal balloon blocker4162 adapted to inflate and deflate is positioned along an inner surfaceof the tube 4100 and when inflated acts to block flow by blockingventilation to the left main stem bronchus. In an embodiment, the distalintraluminal balloon blocker 4162 is a low volume high pressure member.In an embodiment, the member is spherical or elliptical in shape,although any desired shape is possible and within the scope and spiritof the present disclosure.

The tracheal cuff 4132, the bronchial cuff 4152, and the distalintraluminal balloon blocker 4162 are each remotely and selectivelyinflatable through pilot tubes 4232, 4252 and 2624, respectively,running longitudinally through the wall 4110 of the tube 4100 as shownin FIG. 37. The wall 4110 has an internal wall surface, an external wallsurface and a thickness therebetween. Each pilot tube 4232, 4252 and4262 emerges from the outer surface 4101 of the tube 4100 near theproximal end 4102 of the tube 4100. The cable 4332 also emerges from theouter surface 4101 of the tube 4100 near the proximal end 4102 of thetube 4100. Attached to a proximal end of each pilot tube 4232, 4252 and4262 is a non-return valve 4230, 4250 and 4260 which is adapted toreceive the nozzle of a syringe (not visible) and a complementaryindicator bladder 4234, 4254 and 4264 which enables an anesthesiologistto confirm that each of the tracheal cuff 4132, the bronchial cuff 4152,and the distal intraluminal balloon blocker 4162 has been inflated ordeflated. The non-return valves 4230, 4250 and 4260 may be attached to asyringe for injecting a predetermined quantity of air. Various materialsmay be used to form the tracheal cuff 4132, the bronchial cuff 4152 andthe distal intraluminal balloon blocker 4162. These materials include,but are not limited to, polyurethane (PU), low-density polyethylene(LDPE), polyvinyl chloride (PVC), silicone, neoprene, polyisoprene,polyamid (PA) or polyethylene teraphthalate (PETP). Additionally,copolymer admixtures for modifying the characteristics of the materialmay be used, for example a low density polyethylene andethylene-vinylacetate copolymer (LDPE-EVA), or blends of the abovementioned materials (e.g. PU with PVC or PU with PA) would be consideredsuitable for forming the tracheal cuff 4132, the bronchial cuff 4152 andthe distal intraluminal balloon blocker 4162. It is also contemplatedthat in an alternative embodiment of the single lumen endobronchialtube, the distal intraluminal balloon blocker 4162 (as well as the otherco-dependent components of the distal intraluminal balloon blocker 4162including the pilot tube 4262, the non-return valve 4260 and the pilotballoon 4264) are absent. In such an embodiment, a conventionalendobronchial blocker can be used to block ventilation of the left mainstem bronchi.

An aperture 4170 is provided through the wall 4110 of the tube 4100between the tracheal cuff 4132 and the bronchial cuff 4152, as bestillustrated in FIG. 36. The aperture 4170 can be of any shape or size.In an embodiment, the aperture 4170 is dimensioned so that a fiberopticscope can pass through the aperture 170. The amount of medical gaspassing through the aperture 4170 can be controlled using any of themechanisms described above with reference to FIGS. 4-26. In anembodiment, the components of the mechanism are adapted to completelyclose and seal the aperture 4170 such that the amount of medical gaspassing through the aperture 4170 from the lumen 4160 is 0%. In anembodiment, the components of the mechanism are adapted to partiallyclose the aperture 4170 such that the amount of medical gas passingthrough the aperture 4170 from the lumen 4160 is greater than 0% butless than 100%.

In some embodiments, the single lumen endobronchial tube 4100 is adaptedfor use with a PAP machine. In such embodiments, conduits 4282 and 4292(see FIG. 36) run longitudinally through the wall 4110 of the tube 4100to deliver gas to a patient at positive pressure in order to hold openalveoli that would normally close at the end of expiration. The tube4100 can be manufactured to various sizes and adapted to providemechanical ventilation to an air-breathing animal in need thereof. In anembodiment, the tube 4100 is manufactured for human use and ranges insize from about 1.5 mm to about 11 mm in internal diameter (ID). In anembodiment, the tube 4100 is manufactured for human use and ranges insize from about 3 mm to about 10 mm in internal diameter (ID). In anembodiment, the tube 4100 is manufactured for non-human use and rangesin size from about 1.5 mm to about 40 mm in internal diameter (ID). Inan embodiment, the tube 4100 is manufactured for non-human use andranges in size from about 6 mm to about 40 mm in internal diameter (ID).

Referring to FIG. 38, the single lumen endobronchial tube 4100 ispositioned within a patient to facilitate artificial ventilation of therespiratory system. The single lumen endobronchial tube 4100 has beenplaced within a mouth of the patient and positioned such that thetracheal portion 4130 resides within the trachea 1320 and the bronchialportion 4150 resides within the left main stem bronchi 1330. The tube4100 may be sufficiently designed such that the bronchial portion 4150curves for ease of placement beyond the carina 1340 into the left mainstem bronchi 1330. In this placement, ventilation of the left lung orthe right lung can be accomplished without having to move the tube 4100.Placement of the single lumen endobronchial tube 4100 can be performedwith the aid of the video camera 4300 and monitor 4350. Although FIG. 38shows the single lumen endobronchial tube 4100 being inserted throughthe mouth of the patient, it should be understood that the single lumenendobronchial tube 4100 can also be inserted through the nasal passagesinto the airway passage. For one-lung ventilation of the right lung1400, the aperture 4170 remains open, which sufficiently allows the flowof medical gases through the aperture 4170 and into the right lung. Onceproper positioning of the single lumen endobronchial tube 4100 in thepulmonary airway is determined, the bronchial cuff 4152 is inflated to adesired pressure by pushing a fluid such as air or saline through thepilot tube 4252 leading to the bronchial cuff 4152. In an embodiment,the bronchial cuff 4152 is inflated so that the bronchial cuff pressure(BCP) is in the range of about 15 cm H₂O (about 11 mm Hg) to about 30 cmH₂O (about 22 mm Hg). The tracheal cuff 4132 is inflated by pushing afluid such as air or saline through the pilot tube 4232 leading to thetracheal cuff 4132. In an embodiment, the tracheal cuff 4132 is inflatedso that the cuff pressure is in the range of about 15 cm H₂O (about 11mm Hg) to about 30 cm H₂O (about 22 mm Hg). The seal formed by theinflated tracheal cuff 4132 is adapted to substantially provide a sealbetween the outside of the tube 4100 and the interior of the trachea1320 in which the single lumen endobronchial tube 4100 is inserted. Thedistal intraluminal balloon blocker 4162 is inflated by pushing a fluidsuch as air or saline through the pilot tube 4262 leading to the distalintraluminal balloon blocker 4162. In an embodiment, the distalintraluminal balloon blocker 4162 is inflated so that the cuff pressureis in the range of about 20 cm H₂O (about 14.7 mm Hg) to about 95 cm H₂O(about 69 mm Hg). The desired agent(s) are then introduced, for examplefrom an anesthesia machine, through the lumen 4160 of the tube 4100 todeliver the desired agent(s) to the right lung 1400. The inflated distalintraluminal balloon blocker seals the lumen 4160 of the tube 4100distal to the inflated distal intraluminal balloon blocker 4162 suchthat sufficient blockage of the agents to the left lung 1300 isachieved.

For one-lung ventilation of the left lung 1300, the single lumenendobronchial tube 4100 is placed in the pulmonary airway of a patientsuch that the tracheal portion 4130 resides within the trachea 1320 andthe bronchial portion 4150 resides within the left main stem bronchi1330. The tube 4100 may be sufficiently designed such that the bronchialportion 4150 curves for ease of placement beyond the carina 1340 intothe left main stem bronchi 1330. Placement of the single lumenendobronchial tube 4100 can be performed with the aid of the videocamera 4300 and monitor 4350. For one-lung ventilation of the left lung,the aperture 4170 is sealed to sufficiently preclude the flow of medicalgases through the aperture 4170 and into the right lung. Once properpositioning of the single lumen endobronchial tube 4100 in the pulmonaryairway is determined, the bronchial cuff 4152 is inflated to a desiredpressure by pushing a fluid such as air or saline through the pilot tube4252 leading to the bronchial cuff 4152. In an embodiment, the bronchialcuff 4152 is inflated so that the cuff pressure is in the range of about15 cm H₂O (about 11 mm Hg) to about 30 cm H₂O (about 22 mm Hg). The sealformed by the bronchial cuff 4152 is adapted to preclude any medical gasthat has been forced into the patient's left lung from escaping throughthe left main stem bronchi 1330 into the trachea 1320. The tracheal cuff4132 is inflated by pushing a fluid such as air or saline through thepilot tube 4232 leading to the tracheal cuff 4132. In an embodiment, thetracheal cuff 4132 is inflated so that the bronchial cuff pressure (BCP)is in the range of about 15 cm H₂O (about 11 mm Hg) to about 30 cm H₂O(about 22 mm Hg). The seal formed by the tracheal cuff 4132 is adaptedto substantially provide a seal between the outside of the tube 4100 andthe interior of the trachea 1320 in which the single lumen endobronchialtube 4100 is inserted. The desired agent(s) are then introduced, forexample from an anesthesia machine, through the lumen 4160 of the tube4100 to deliver the desired agent(s) to the left lung 1300.

In an embodiment, a single lumen endobronchial tube of the presentdisclosure can be used in general anesthesia, intensive care, andemergency medicine for airway management and mechanical ventilation. Inan embodiment, a single lumen endobronchial tube of the presentdisclosure can be used during any procedure where lung separation isnecessary to isolate and selectively ventilate a single lung, including,but not limited to, thoracic surgical procedures, lung abscess surgicalprocedures, and pulmonary hemorrhage surgical procedures. In someembodiments, a single lumen endobronchial tube of the present disclosureis used with a BiPAP machine. In some embodiments, a single lumenendobronchial tube of the present disclosure is used with a CPAPmachine. In such embodiments, the proximal end of the medical tube isconnected to the PAP machine such that compressed air is delivereddirectly to the pulmonary airway of a patient. Use of a single lumenendobronchial tube of the present disclosure in conjunction with a CPAPmachine may be useful in treating or preventing various conditions inpatients, including, but not limited to, obstructive sleep apnea andrespiratory failure.

In some embodiments, a single lumen endobronchial tube of the presentdisclosure is used with an anesthesia machine. In such embodiments, theproximal end of the medical tube is connected to the anesthesia machinesuch that medical gases are delivered to the pulmonary airway of anair-breathing animal. Use of a single lumen endobronchial tube of thepresent disclosure in conjunction with an anesthesia machine may beuseful to support the administration of anesthesia to the animal.

A method of selective left lung bronchial occlusion for right lungventilation of a patient includes inserting a single lumen endobronchialtube into the pulmonary airway of a patient, the tube having: a lumenextending throughout the tube's entire length with an opening at each ofopposed distal and proximal ends of the tube, the opening at theproximal end of the tube being adapted for connection to an externalmechanical ventilation device, and the opening at the distal end of thetube being adapted for delivery of a medical gas; a wall extendingthroughout the tube's entire length having an internal wall surface, anexternal wall surface and a thickness therebetween, a portion of thewall having an aperture and a shaft adapted to house a mechanism forsealing the aperture; a distal bronchial cuff positioned along theexternal wall surface and adapted to expand radially outward; a proximaltracheal cuff positioned along the external wall surface and adapted toexpand radially outward; and a distal intraluminal balloon blocker at arespective distal location relative to the aperture; positioning thetube in the pulmonary airway such that the distal bronchial cuff is inthe left main stem bronchus, and the proximal tracheal cuff is in thetrachea; inflating the distal bronchial cuff radially outwardly to sealagainst the surrounding bronchus of the left lung; inflating theproximal tracheal cuff radially outwardly to seal against thesurrounding trachea of the patient; inflating the distal intraluminalballoon blocker radially outwardly to occlude the lumen of the tube andthereby effectively occlude the left lung, whereby an airway from theventilation device to the patient's right lung is maintained via theaperture.

A method of selective right lung bronchial occlusion for left lungventilation of a patient includes inserting a single lumen endobronchialtube into the pulmonary airway of a patient, the tube having: a lumenextending throughout the tube's entire length with an opening at each ofopposed distal and proximal ends of the tube, the opening at theproximal end of the tube being adapted for connection to an externalmechanical ventilation device, and the opening at the distal end of thetube being adapted for delivery of a medical gas; a wall extendingthroughout the tube's entire length having an internal wall surface, anexternal wall surface and a thickness therebetween, a portion of thewall having an aperture and a shaft adapted to house a mechanism forsealing the aperture; a distal bronchial cuff positioned along theexternal wall surface and adapted to expand radially outward; a proximaltracheal cuff positioned along the external wall surface and adapted toexpand radially outward; and a distal intraluminal balloon blocker at arespective distal location relative to the aperture; positioning thetube in the pulmonary airway such that the distal bronchial cuff is inthe left main stem bronchus, and the proximal tracheal cuff is in thetrachea; inflating the distal bronchial cuff radially outwardly to sealagainst the surrounding bronchus of the left lung; inflating theproximal tracheal cuff radially outwardly to seal against thesurrounding trachea of the patient; and sealing the aperture byactivating the mechanism housed in the shaft of the wall of the tube toblock the aperture and thereby effectively occlude the right lung,whereby an airway from the ventilation device to the patient's left lungis maintained via the opening at the distal end of the tube.

A method for one-lung ventilation of a lung of an air-breathing animalincludes providing a single lumen endobronchial tube, the single lumenendobronchial tube comprising a medical tube having a single lumen withan opening at each of opposed distal and proximal ends of the tube, theopening at the proximal end of the tube being adapted for connection toan external mechanical ventilation device, and the opening at the distalend of the tube being adapted for delivery of a medical gas; a wallextending throughout the tube's entire length having an internal wallsurface, an external wall surface and a thickness therebetween, aportion of the wall having an aperture and a shaft adapted to house amechanism for sealing the aperture; a distal bronchial cuff positionedalong the external wall surface and adapted to expand radially outward;at least a first proximal tracheal cuff positioned along the externalwall surface and adapted to expand radially outward; and a distalintraluminal balloon blocker at a respective distal location relative tothe aperture; positioning the single lumen endobronchial tube in thepulmonary airway of the animal such that the distal bronchial cuff is inthe left main stem bronchus, and the first proximal tracheal cuff is inthe trachea, wherein a distal end of the medical tube is positionedbeyond the carina of the animal; connecting the proximal end of themedical tube to the external mechanical ventilation device; inflatingthe distal bronchial cuff radially outwardly to seal against thesurrounding bronchus of the left lung; inflating the proximal trachealcuff radially outwardly to seal against the surrounding trachea of theanimal; and performing a step selected from one of inflating the distalintraluminal balloon blocker radially outwardly to occlude the lumen ofthe tube and thereby effectively occlude the left lung, whereby anairway from the ventilation device to the animal's right lung ismaintained via the aperture or sealing the aperture by activating themechanism housed in the shaft of the wall of the tube to block theaperture and thereby effectively occlude the right lung, whereby anairway from the ventilation device to the anima's left lung ismaintained via the opening at the distal end of the tube.

All patents, patent applications, and published references cited hereinare hereby incorporated by reference in their entirety. It will beappreciated that various of the above-disclosed and other features andfunctions, or alternatives thereof, may be desirably combined into manyother different systems or applications. Various presently unforeseen orunanticipated alternatives, modifications, variations, or improvementstherein may be subsequently made by those skilled in the art which arealso intended to be encompassed by the following claims.

What is claimed is:
 1. A method for one-lung ventilation of a lung of anair-breathing animal comprising: providing a single lumen endobronchialtube, the single lumen endobronchial tube comprising: a medical tubehaving a single lumen with an opening at each of opposed distal andproximal ends of the tube, the opening at the proximal end of the tubebeing adapted for connection to an external mechanical ventilationdevice, and the opening at the distal end of the tube being adapted fordelivery of a medical gas; a wall extending throughout a length of thetube and having an internal wall surface, an external wall surface and athickness therebetween, a portion of the wall having an aperture sealedby a mechanism similar in size to the aperture; a distal bronchialinflatable cuff positioned along the external wall surface and adaptedto expand radially outward; at least a first proximal trachealinflatable cuff positioned along the external wall surface and adaptedto expand radially outward; and a distal intraluminal balloon blocker ata respective distal location relative to the aperture; positioning thesingle lumen endobronchial tube in the pulmonary airway of the animalsuch that the distal bronchial inflatable cuff is in the left main stembronchus, and the first proximal tracheal inflatable cuff is in thetrachea, wherein a distal end of the medical tube is positioned beyondthe carina of the animal; connecting the proximal end of the medicaltube to the external mechanical ventilation device; inflating the distalbronchial inflatable cuff radially outwardly to seal against thesurrounding bronchus of the left lung; inflating the proximal trachealinflatable cuff radially outwardly to seal against the surroundingtrachea of the animal; and performing a step selected from one of:delivering the medical gas through the medical tube to ventilate theleft lung, or delivering the medical gas through the medical tube toventilate the right lung by inflating the distal intraluminal balloonblocker radially outwardly to occlude the lumen of the tube toeffectively occlude the left lung and unsealing the aperture.
 2. Themethod of claim 1 wherein the air-breathing animal is a human and themedical tube has an internal diameter ranging from about 1.5 mm to about11.0 mm.
 3. The method of claim 1 wherein the air-breathing animal is anon-human and the medical tube has an internal diameter ranging fromabout 1.5 mm to about 40.0 mm.
 4. The method of claim 1 wherein thesingle lumen endobronchial tube further comprises a built-in videocamera embedded within the tube wall for real-time visualization.
 5. Themethod of claim 1 wherein the distal intraluminal balloon blocker is alow volume high pressure member.
 6. The method of claim 1 wherein thefirst proximal tracheal inflatable cuff, the distal bronchial inflatablecuff and the distal intraluminal balloon blocker are each remotely andselectively inflatable.
 7. The method of claim 1 wherein the tube wallof the endobronchial tube further comprises at least one conduit for thepassage of a gas.